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Life-Long Monitoring of Diabetes Mellitus in Veneto Region

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ClinicalTrials.gov Identifier: NCT01569893
Recruitment Status : Completed
First Posted : April 3, 2012
Last Update Posted : October 28, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
To evaluate whether patients with type 2 diabetes mellitus can be followed by simplified, centralized and large scale tele-monitoring of blood glucose levels, and whether this intervention produces health and economic benefits when introduced without major changes to the existing organization of a large treatment care center.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Other: Self-monitoring for patients with Dibetes mellitus

Detailed Description:
The study is designed to evaluate the impact of telemonitoring on the management of Diabetes Mellitus compared with outpatient usual care. From a clinical point of view, the measurements of HbA1c will be taken to assess glycaemic control and the trial will allow to investigate how telemonitoring contributes to improve Diabetes mellitus patients health-related quality of life and reduct the access to hospital facilities (re-hospitalizations, bed-days, specialistic and ER visits) and the anxiety about health conditions. A cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. The evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professionals perception towards the service.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 598 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: RENEWING HEALTH - Large Scale Pilot in Veneto Region: Life-long Monitoring of Diabetes Mellitus
Study Start Date : March 2012
Primary Completion Date : May 2014
Study Completion Date : May 2014
Arms and Interventions

Arm Intervention/treatment
No Intervention: Control group
Usual care: treatment as usual
Experimental: Self-monitoring for patients with Dibetes mellitus type 2
Self-monitoring for patients with Dibetes mellitus type 2
Other: Self-monitoring for patients with Dibetes mellitus

Patients are equipped with a telemonitoring kit composed by a portable glucose meter and a gateway device for data transmission.

The patient can monitor his blood glucose level with a frequency set by the clinician in the personalised treatment plan. Data are transmitted to a regional eHealth centre where a group of operators keeps these information under control and alert the reference clinician in case of worsening of symptoms.

Outcome Measures

Primary Outcome Measures :
  1. Health related quality of life of the patients measured by the SF-36 version 2 questionnaire [ Time Frame: At the entry point of intervention and at the end (12 months) ]
  2. Glycated hemoglobin (HbA1c) levels [ Time Frame: At the entry point of intervention and at the end (12 months) ]

Secondary Outcome Measures :
  1. Number of hospitalisations. [ Time Frame: 12 months ]
  2. Number of hospitalisations due to diabetes. [ Time Frame: 12 months ]
  3. Bed days of care [ Time Frame: 12 months ]
  4. Bed days of care due to diabetes. [ Time Frame: 12 months ]
  5. Number of visits with specialists [ Time Frame: 12 months ]
  6. Number of access to ER [ Time Frame: 12 months ]
  7. Mental status measured through Hospital Anxiety and Depression Scale (HADS). [ Time Frame: At the entry point of intervention and at the end (12 months) ]
  8. Number of visits with specialists in diabetic center [ Time Frame: 12 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of type 2 Diabetes
  • HbA1c > 53 mmol/mol (7.0 % according to NGSP)
  • Capability to use the devices provided
  • Being cognitively able to participate
  • Capability of filling in questionnaires in german or greek or italian language
  • Absence of severe comorbidity prevalent on diabetes with life expectancy < 12 months

Exclusion Criteria:

  • Pregnancy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569893

"De Lellis" Hospital - Diabetology-Endocrinology Department
Schio, Vicenza, Italy, 36015
Sponsors and Collaborators
Regione Veneto
European Commission
Azienda ULSS 4 Alto Vicentino
Principal Investigator: Francesco Calcaterra, MD Local Health Authority "Alto Vicentino" of Thiene (VI)
More Information

Additional Information:
Responsible Party: Regione Veneto
ClinicalTrials.gov Identifier: NCT01569893     History of Changes
Other Study ID Numbers: G. A. 250487 - Veneto WP8Cl2
First Posted: April 3, 2012    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: January 2014

Keywords provided by Regione Veneto:
Diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases